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4,758 catalysts · 4,758 device 510k · 4,728 grant · 3,606 8k filing · 3,500 approval · 2,000 device pma · 2,000 device recall

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type: device 510k×from 2024-10-23×clear all
type
  • device 510k4,758
  • grant4,728
  • 8k filing3,606
  • approval3,500
  • device pma2,000
  • device recall2,000
recall
1,126
  • device adverse event1,000
  • earnings585
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Oct 21, 2024

    48
    ›Oct 23, 2024device 510k678d agoL&K BIOMED Co., Ltd. — BluEX Lumbar Expandable Cage System (510k cleared)NeuCen BioMed Co Ltd

    Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoMim Software, Inc. — MIM – Symphony HDR Fusion (510k cleared)ASURE SOFTWARE INC

    Product code: LLZ. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoEpic Medical Pte. , Ltd. — ProSeal™ Closed System Bag Access (510k cleared)

    Product code: ONB. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoVarian Medical Systems — Vitesse (5.0) (510k cleared)

    Product code: MUJ. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoGuangdong Optomedic Technologies, Inc. — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (510k cleared)

    Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ Spinal System (510k cleared)Medtronic USA Inc

    Product code: NKB. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus; TrueFlex Bolus (510k cleared)Medical Care Technologies Inc.

    Product code: MUJ. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoDRTECH Corporation — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); (510k cleared)

    Product code: KPR. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoAffinity Biosensors, LLC — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (510k cleared)

    Product code: SAN. Advisory committee: Microbiology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoSpineart SA — Scarlet® AL-T (510k cleared)

    Product code: MAX. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoThe Orthopaedic Implant Company — OIC Small / Mini Fragment Plate System (510k cleared)

    Product code: HRS. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoScivita Medical Technology Co., Ltd. — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (510k cleared)NewBay Medical Technology Co Ltd

    Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoParagonix Technologies — KIDNEYvault Portable Renal Perfusion System (510k cleared)

    Product code: KDN. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoBiomet 3i, LLC — Immediate Molar Implants (510k cleared)

    Product code: DZE. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoWeifang Mingliang Electronics Co., Ltd. — Fractional CO2 Laser Therapy System (EXFU CO2) (510k cleared)

    Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoImmunodiagnostic Systems Limited — IDS-iSYS Free Testosterone (510k cleared)Transdermal Delivery Solutions Corp

    Product code: CDZ. Advisory committee: Clinical Chemistry. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 23, 2024device 510k678d agoTsk Laboratory International Japan KK — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (510k cleared)

    Product code: QYM. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoTelefield Medical Imaging (Shenzhen) Limited — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (510k cleared)

    Product code: IYN. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoMedtronic Neurosurgery — Duet External Drainage and Monitoring System (EDMS) (510k cleared)

    Product code: PCB. Advisory committee: Neurology. Type: Special

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoGt Metabolic Solutions, Inc. — MagDI System (MAG-01, DS-01) (510k cleared)Seed Health Inc

    Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoMedency S.R.L. — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) (510k cleared)

    Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoDentsply Sirona — CEREC Cercon 4D CAD/CAM Blocks (510k cleared)DENTSPLY SIRONA Inc.

    Product code: EIH. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoImplantcast GmbH — MUTARS® femoral stem cemented 160 mm and 200 mm (510k cleared)

    Product code: LZO. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoArgen Corporation — ArgenZ MTZ (510k cleared)

    Product code: EIH. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoKeystone Industries — KeyPrint KeyDenture Base (510k cleared)

    Product code: EBI. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoFoshan Shunkangda Medical Tech Co., Ltd. — Manual Wheelchair (SYIV100-CA9221) (510k cleared)

    Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 24, 2024device 510k677d agoPhilips Medical Systems Nederland B.V. — ROCC Console (510k cleared)

    Product code: LLZ. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

    Product code: QIH. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitors C310S, G310S, C316S, G316S, C616W (510k cleared)

    Product code: PGY. Advisory committee: Radiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoShenzhen Yimi Life Technology Co., Ltd. — Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

    Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoNorlase Aps — LYNX Photocoagulator (510k cleared)

    Product code: HQF. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoAvanos Medical, Inc. — CORGRIP* SR NG/NI Tube Retention System (510k cleared)AVANOS MEDICAL, INC.

    Product code: KNT. Advisory committee: Gastroenterology, Urology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoMetko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi — FMT Disposable and Autoclavable Temperature Probes (510k cleared)

    Product code: FLL. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoNeurophet., Inc. — Neurophet AQUA (V3.1) (510k cleared)NeurOp Inc

    Product code: QIH. Advisory committee: Radiology. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoOrtho Development Corp. — BKS Revision System (510k cleared)DeFi Development Corp.

    Product code: JWH. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoCryoconcepts LP — Freeze Point & Private Label Versions (510k cleared)

    Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d ago3D Systems, Inc. — Cadence Ankle PSI System (510k cleared)3D SYSTEMS CORP

    Product code: OYK. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoOcuject, LLC — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (510k cleared)

    Product code: QNS. Advisory committee: General Hospital. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoDistalmotion SA — Dexter L6 System (510k cleared)

    Product code: SDD. Advisory committee: General, Plastic Surgery. Type: Direct

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoBruno Vision Care, LLC — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism (510k cleared)

    Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoUlike Co., Ltd. — Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) (510k cleared)

    Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d ago3D Systems, Inc. — Salto Talaris Ankle PSI System (510k cleared)3D SYSTEMS CORP

    Product code: OYK. Advisory committee: Orthopedic. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoBiotronik, Inc. — Pantera Pro; Pantera LEO (510k cleared)

    Product code: LOX. Advisory committee: Cardiovascular. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoQIAGEN GmbH — QIAstat-Dx Respiratory Panel Mini (510k cleared)

    Product code: QOF. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoVATECH Co., Ltd. — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (510k cleared)

    Product code: MUH. Advisory committee: Dental. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoCepheid® — Xpert® SA Nasal Complete (510k cleared)

    Product code: NQX. Advisory committee: Microbiology. Type: Special

    full page →fda device 510k ↗
    ›Oct 25, 2024device 510k676d agoComfort Rubber Gloves Industries Sdn. Bhd. — Nitrile Powder Free Examination Gloves Biodegradable (Green) (510k cleared)

    Product code: LZA. Advisory committee: General Hospital. Type: Traditional

    full page →fda device 510k ↗

    Week of Oct 28, 2024

    2
    ›Oct 28, 2024device 510k673d agoMedtronic Sofamor Danek USA, Inc. — Catalyft™ LS Expandable Interbody System (510k cleared)Medtronic USA Inc

    Product code: OVD. Advisory committee: Orthopedic. Type: Traditional

    full page →fda device 510k ↗
    ›Oct 28, 2024device 510k
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    673d ago
    Ethicon Endo-Surgery, LLC — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) (510k cleared)

    Product code: GDW. Advisory committee: General, Plastic Surgery. Type: Traditional

    full page →fda device 510k ↗
    $FRTRY
    $DFUKF
    $AVNS
    $FRTRY
    $MDCE0.00020.00%
    $ASUR8.2700+1.35%
    $DDD
    $XRAY11.12+0.72%
    $DDD